MedTrace Logo

Establish MeMed BV™ Performance for Differentiating Bacterial From Viral Infection in Suspected Acute Infection Patients (APOLLO STUDY)

NCT04690569 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1384

Last updated 2021-01-05

No results posted yet for this study

Summary

Prospective, multi-center, observational, blinded study, enrolling pediatric and adult subjects. Eligible ED\\Urgent care and hospital admitted patients with symptoms consistent with acute bacterial or viral infection and healthy subjects will be recruited according to the eligibility criteria. Each participant will undergo a thorough investigation upon recruitment that includes documenting clinical, radiological, laboratory and microbiological information for determining their health status.

Follow-up data will be collected via a phone call. Diagnostic performance of the MeMed BV™ Test for differentiating bacterial from viral infection will be assessed using an expert adjudication comparator method.

The study will be run in a blinded fashion: site personnel will be blinded to the comparator method outcomes, and the expert panel will be blinded to the results of the index test. Results of the index test will not be revealed to the attending clinician and so will not influence patient management.

Conditions

  • Acute Infection

Interventions

DIAGNOSTIC_TEST

MeMed BV

The MeMed BV™ Test is an immunoassay that measures three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatric serum samples. The test is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection. The test is indicated for use in patients presenting to the ED, urgent care center and inpatients with suspected acute bacterial or viral infection. The MeMed BV™ Test generates a numeric score that falls within discrete interpretation bins based on the increasing likelihood of bacterial infection. The MeMed BV™ test is intended for in vitro diagnostic use only.

Sponsors & Collaborators

  • MeMed Diagnostics Ltd.

    lead INDUSTRY

Eligibility

Min Age
90 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-03
Primary Completion
2020-11-22
Completion
2020-11-22
FDA Device
Yes

Countries

  • United States
  • Israel

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04690569 on ClinicalTrials.gov